Observational Study on Non-steroid Anti-inflammatory Drugs (NSAIDs) Treated Patients With Arthritic Disorder (EVIDENCE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01176682
First received: July 30, 2010
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

The aim of this study is to find out how patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving NSAID-therapy are treated and managed by their doctor in usual clinical practice, how patients comply with their treatment and how satisfied they are with their treatment.


Condition
Osteoarthritis
Rheumatoid Arthritis
Ankylosing Spondylitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Real Life Study on NSAIDs Treated Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS): Assessment of Pain Relieve, Gastrointestinal (GI) Symptoms, Adherence and Health Resource Consumption

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The incidence of selected GI events, classified as "symptomatic" or "complicated" GI events. Reported by the patients at the follow-up visits. [ Time Frame: Time from NSAID treatment prescription to first diagnosis of the GI event for each patient will be registered. Each patient will be followed up for 6 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of health care visits and days of hospitalisation (health care consumption) related to arthritic disorder and/or GI events as reported by the patients at the follow-up visits. [ Time Frame: Health care consumption accumulated over the 6 months study period will be registered. ] [ Designated as safety issue: No ]
  • Quality of life assessed by EuroQol-5 Dimension (EQ-5D) at baseline and the follow-up visits. Measure how selected GI events impact the EQ-5D score. [ Time Frame: Measurements at baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Adherence with NSAIDs and proton pump inhibitors (PPI) measured by Morisky-Green-Levine Medication Assessment Scale (MMAS) at baseline and follow-up visits. [ Time Frame: Measurements at baseline, 3 months and 6 months ] [ Designated as safety issue: No ]

Enrollment: 1149
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Adult patients treated with NSAID therapy for diagnosed OA, RA or AS, and with GI risk factors

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients treated with NSAID therapy for diagnosed OA, RA or AS, and with GI risk factors. The patients will be asked to participate by their treating doctors at GP centres, specialist centres or hospitals.

Participating investigators will belong to a variety of centres representing the reality of how and where these patients are managed in each country.

Criteria

Inclusion Criteria:

  • Diagnosis of arthritic disorder (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis)
  • Already receiving NSAID treatment at enrolment visit

Exclusion Criteria:

  • Inability to complete the study related questionnaires
  • Current participation in any interventional study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176682

  Show 244 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Javier Nuevo, MSc Medical Department.AstraZeneca Spain
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01176682     History of Changes
Other Study ID Numbers: NIS-GEU-DUM-2010/1
Study First Received: July 30, 2010
Last Updated: June 5, 2012
Health Authority: Belgium: Institutional Review Board
France: National Consultative Ethics Committee for Health and Life Sciences
France: French Data Protection Authority
Germany: Ethics Commission
Greece: Ethics Committee
Greece: Ministry of Health and Welfare
Italy: Ethics Committee
Netherlands: Independent Ethics Committee
Norway:National Committee for Medical and Health Research Ethics
Portugal: Ethics Committee for Clinical Research
Spain: Ethics Committee
Sweden: Regional Ethical Review Board
Switzerland: Ethikkommission
Turkey: Ministry of Health
United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:
NSAID-treated patients
gastrointestinal events
Non-steroid anti-inflammatory drug (NSAID)
Gastrointestinal events (GI events)
Proton Pump Inhibitors (PPI)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Proton Pump Inhibitors
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014